Multiple CoolSculpting Treatment Study

Blood draws will be collected pre-treatment, 1-week, 4-weeks, 12-weeks post treatment. Changes in each analyte was evaluated for consistency with normal variation and for change relative to the reference range of the component (high/low), pre-treatment versus post-treatment by an independent physician. The independent physician reviewer was provided with laboratory results and other pertinent information for each subject, including demographic, medical history, and concomitant medications. For every change in laboratory value over time, the reviewer was required to make a determination of whether the change in value represented a clinically meaningful change. In addition, for any change in a laboratory value that exceeded 25% change, or any value outside of normal range, the reviewer was required to provide a written rationale for the determination of clinical meaningfulness.

Time frame: Pre-treatment; 1 week, 4 weeks, and 12 weeks post-treatment

Population: Blood draws completed on 35 subjects at baseline. Two liver-related test results unavailable for 1 subject at baseline. Blood draws at the 1 week, 4 week and 12 week time periods reflect 34 subjects as one of the 35 subjects enrolled withdrew from the study. Liver-related test values were analyzed for each time point.

Blood draws will be collected pre-treatment, 1-week, 4-weeks, 12-weeks post treatment. Changes in each analyte was evaluated for consistency with normal variation and for change relative to the reference range of the component (high/low), pre-treatment versus post-treatment by an independent physician. The independent physician reviewer was provided with laboratory results and other pertinent information for each subject, including demographic, medical history, and concomitant medications. For every change in laboratory values over time, the reviewer was required to make a determination of whether the change in value represented a clinically meaningful change. In addition, for any change in a laboratory value that exceeded 25% change, or any value outside of normal range, the reviewer was required to provide a written rationale for the determination of clinical meaningfulness.

Time frame: Pretreatment, 1 week, 4 weeks 12 weeks post-treatment

Population: Total bilirubin test results were not available for 2 subjects for the baseline visit. Of the 35 subjects enrolled in the study, 1 subject withdrew from the study and had no further blood draws.

Blood draws will be collected pre-treatment, 1-week, 4-weeks, 12-weeks post treatment. Changes in each analyte was evaluated for consistency with normal variation and for change relative to the reference range of the component (high/low), pre-treatment versus post-treatment by an independent physician. The independent physician reviewer was provided with laboratory results and other pertinent information for each subject, including demographic, medical history, and concomitant medications. For every change in laboratory values over time, the reviewer was required to make a determination of whether the change in value represented a clinically meaningful change. In addition, for any change in a laboratory value that exceeded 25% change, or any value outside of normal range, the reviewer was required to provide a written rationale for the determination of clinical meaningfulness.

Time frame: Pre-treatment, 1 week, 4 weeks, 12 weeks post-treatment

Population: Of the 35 subjects enrolled, 1 subject withdrew and did not have blood draws performed after the baseline visit.

The primary safety end point is the incidence of Serious Adverse Events (SAE) and Unanticipated Adverse Device Effects (UADE).

Time frame: 12 weeks post treatment

Population: All treated subjects were included in the safety analysis population.

Pain scores are collected using a 0 (no pain) to 10 (worst possible pain) scale. Scores will be collected immediately post-treatment and at the 12 week follow-up visit.

Time frame: Treatment day and 12 week post-treatment follow-up

Population: All subjects treated with the CoolSculpting System were included in the analysis population. One (1) subject was withdrawn from the study by the investigator after treatment, therefore pain scores reflect 35 subjects analyzed.

All adverse will be assessed for frequency and severity from the time of enrollment though the 12 week follow-up visit.

Time frame: 12 weeks post-treatment

Population: All subjects treated with the CoolSculpting device were included in the analysis population.

Clinical assessments of the skin at the treatment sites to be performed immediately post-treatment, and at the 12 week follow-up visit. Subjects will be evaluated for skin changes at the treatment sites. The scale used by clinicians for the assessments is 0 = absent, 1= minor, 2= moderate, 3= severe.

Time frame: Treatment day and 12 week post-treatment follow-up

Population: The analysis population included all subjects treated with the CoolSculpting System. 1 subject did not complete the final follow-up visit. The abdomen, left and right flanks were clinically assessed immediately post treatment and at 12 weeks. At 12 weeks, 102 treatment sites were assessed.