MAUDE Adverse Event Report: CSA MEDICAL, INC. TRUFREEZE; TRUFREEZE CONSOLE

Model Number	CC3-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pleural Effusion (2010)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that following two trufreeze procedures, both patients experienced post procedure discomfort.The patients were both readmitted for additional care.After a ct evaluation was conducted, a right pleural effusion was detected in both patients.The second day following both procedures, the patients were discharged to go home with no lasting effects reported.Medication was administered to both patients following discharge.It is unknown what type of medication was administered.
Additional Manufacturer Narrative
The active venting sprays subject of the reported events were discarded by the user facility and not available for evaluation.The log files for the trufreeze console system were reviewed and no issues were noted with the function or operation.The instructions for use states, "do not use the product if the device does not function properly or there is evidence of damage (e.G.Kinks, bends or damaged packaging).Save the device and packaging and contact your local steris endoscopy product specialist." the ifu further states, " the physician should carefully consider patient eligibility for cryospray ablation (i.E., cryosurgery and associated gas pressure), including patient presentation, medical history, co-morbidities (e.G., copd, cad), and prolonged use of steroids that may reduce the patient's tissue compliance and tissue strength affecting their ability to tolerate cryospray.Any therapy or procedure compromising the integrity of the tissue, specifically in or adjacent to the targeted ablation area.The physician should use caution when applying cryospray in any organ where stricture or collapse is likely.The physician should use caution when considering cryospray for this high-risk patient situation, specifically regarding the ability to vent or extract gas.Physicians should use caution in any procedure or anatomy where a restriction or obstruction interferes with the adequate venting or nitrogen as, resulting in increased gas pressure.During cryospray, the patient must be monitored for abdominal distention and cryospray must be stopped if the abdomen becomes distended, if using in the esophagus.Liquid nitrogen expands more than 700 times when changing from a liquid to a gaseous state.It is imperative for patient safety that adequate venting is used to remove gas created during cryospray." no additional issues have been reported.
Additional Manufacturer Narrative
One of the two devices subject of the reported event was returned to steris endoscopy for evaluation.The returned catheter was evaluated by steris engineering and confirmed there were no visible kinks, breaks or bends in the device that would attribute to the reported issue.Additionally, the catheter sprayed as expected when tested.The reported event could not be duplicated.Steris offered in-service training on the proper use and operation of the trufreeze system console; however, the user facility declined.No additional issues have been reported.

• Brand Name: TRUFREEZE
• Common Device Name: TRUFREEZE CONSOLE
• Manufacturer (Section D): CSA MEDICAL, INC.; 5976 heisley road; mentor OH
• Manufacturer (Section G): CSA MEDICAL, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4404130648
• MDR Report Key: 20678142
• Report Number: 1528319-2024-00100
• Device Sequence Number: 15546281
• Product Code: GEH
• UDI-Device Identifier: 00857068006006
• UDI-Public: (01)00857068006006
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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: CC3-01
• Device Catalogue Number: CC3-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown