MAUDE Adverse Event Report: CHANNEL MEDSYSTEMS, INC. CERENE CRYOTHERAPY DEVICE; ENDOMETRIAL ABLATION DEVICE

Model Number	FGS-7000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	04/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation of the device was not possible, as the device was discarded.The lot number was reported, so device history records were reviewed, with no deviations in the production record noted.Four episodes of presyncope were reported in the clarity pivotal study for the cerene cryotherapy device and are reported in the instructions for use.
Event or Problem Description
Prior to treatment with the cerene cryotherapy device, the patient received a paracervical block and experienced ringing in her ears and a racing heart.After 2-2.5 hours of waiting at the physician's facility, the patient and physician decided to proceed with cerene treatment.The procedure was completed succesfully.Following the procedure, the patient was accompanied to the parking lot by her husband, where she lost consciousness.The patient was transferred to the emergency room and accompanied by the physician.The patient was released the same day from the hospital.

• Brand Name: CERENE CRYOTHERAPY DEVICE
• Common Device Name: ENDOMETRIAL ABLATION DEVICE
• Manufacturer (Section D): CHANNEL MEDSYSTEMS, INC.; 2919 7th street; berkeley CA 94710
• Manufacturer (Section G): CHANNEL MEDSYSTEMS, INC.; 2919 7th street; berkeley CA 94710
• Manufacturer Contact: kathleen gallo ; 2919 7th street; berkeley, CA 94710 ; 5103389301
• MDR Report Key: 25165730
• Report Number: 3012018285-2026-00001
• Device Sequence Number: 10474240
• Product Code: MNB
• UDI-Device Identifier: 00850008595035
• UDI-Public: (01)00850008595035(11)250916(17)270317(10)114226858
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P180032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: FGS-7000
• Device Lot Number: 114226858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female