Important 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.
Physician Labeling Cerene Cryotherapy Device
Physician Labeling Cerene Exhaust Collection Bag
Patient Labeling
Electronic IFUs can be viewed using Adobe Acrobat Reader. This software can be downloaded free of charge at https://get.adobe.com/reader/
Printed IFUs can be provided to healthcare professionals free of charge within 7 calendar days. Please make your request by emailing shipping@cerene.com and include your shipping address and the IFUs you are requesting.
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