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

Model Number	FGS-7000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Abscess (1690); Fever (1858); Pelvic Inflammatory Disease (2000); Sepsis (2067); Urinary Tract Infection (2120)
Date of Event	04/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician performed a procedure with the cerene cryotherapy device on april 5th.The procedure went well; there were no malfunctions or issues noted and it was a normal procedure.The patient was 46 years old and had a medical history of c-section and sterilization through an essure procedure (hysteroscopic procedure).Two weeks post-procedure, the patient had fever without abdominal pain.Her general practitioner suspected a urinary tract infection and started antibiotics.Three weeks after the procedure, she developed abdominal pain and was referred to the local hospital.She was admitted with sepsis, received a ct scan (which revealed an infection inside the uterus [endometritis]), and was given antibiotics.Another ct scan was performed because she had a relapse with increasing infection parameters; an abscess of 16cm between the bladder and the uterus as well as above the uterus was seen.No uterine perforation was seen.The patient was given antibiotics and a drain.The patient persisted with high fever and was moved to the (b)(6) hospital in (b)(6) on may 12th where she was again given a ct scan and drained.Thrombosis in the left ovarian vein was found.She was given different antibiotics.On may 19th the patient left the hospital with antibiotics and a drain and is recovering.
Additional Manufacturer Narrative
Device was discarded.If the lot number of the device used can be determined, production records will be analyzed.
Additional Manufacturer Narrative
The cause of reported infection is undetermined.Microbiological assessment confirmed the presence of actinomyces, but the exact cause of the infection is unknown.Infection post-treatment is addressed in the risk management documentation and presented in labeling.As no lot number was reported and the manufacturer was unable to isolate the lot number (several lot numbers were sold to this account), no lot history or production records could be analyzed.
Event or Problem Description
As of july 1st, the drain had been removed, infection levels were low, and the patient will receive antibiotics for 3 months.Microbiological assessment showed "actinomyces.".

• Brand Name: CERENE CRYOTHERAPY DEVICE
• Common Device Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): CHANNEL MEDSYSTEMS; 2919 7th street; berkeley CA 94710
• Manufacturer (Section G): CHANNEL MEDSYSTEMS; 2919 7th street; berkeley CA 94710
• Manufacturer Contact: kathleen gallo ; 2919 7th street; berkeley, CA 94710 ; 5103389301
• MDR Report Key: 19512893
• Report Number: 3012018285-2024-00020
• Device Sequence Number: 3418656
• Product Code: MNB
• UDI-Device Identifier: 00850008595035
• UDI-Public: 00850008595035
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P180032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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
• Operator of Device: Health Professional
• Device Model Number: FGS-7000
• 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: 05/23/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention; Hospitalization
• Patient Age: 46 YR
• Patient Sex: Female