Safety Information
Important Safety Information

Cerene® Cryotherapy Device is indicated to ablate the endometrial lining of the uterus in premenopausal women with heavy menstrual bleeding due to benign causes for whom childbearing is complete. Pregnancy following the Cerene procedure can be dangerous; therefore, contraception must be used until menopause. The Cerene procedure is not for those who have or suspect uterine cancer; have an active genital, urinary or pelvic infection; or an IUD. There are risks and considerations associated with the use of the Cerene Cryotherapy Device. Temporary side effects may include uterine cramping, vaginal infection, and lightheadedness. For detailed benefit and risk information, consult the Cerene Instructions for Use (IFU) or your healthcare professional. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician trained in the use of the Cerene Cryotherapy Device.

Caution

Federal (USA) law restricts this device to sale by or on the order of a physician trained in the use of the Cerene Cryotherapy Device.

To report a product complaint or adverse event, please contact

Channel Medsystems at quality@cerene.com or
FDA at 1-800-FDA-1088 or www.fda.gov/medwatch