MAUDE Adverse Event Report: ENTELLUS MEDICAL, INC. CLARIFIX; UNIT, CRYOSURGICAL, ACCESSORIES

Catalog Number	CFX2000
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Codes	Syncope/Fainting (4411); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 15 events were reported for this quarter.Product return status: 15 devices had investigation types that have not yet been determined.Evaluation findings (results/components): 15 devices: results pending completion of investigation / part/component/sub-assembly term not applicable.Product disposition: 15 devices: product disposition is not yet determined.Additional information: 15 devices were labeled for single-use.15 devices were not reprocessed or reused.
Event or Problem Description
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between july 1 ¿ september 30, 2025.This report summarizes 15 events for the failure: free or unrestricted flow.1 event had problem identified before clinical use/exposure; there was no patient involvement.13 events had no health consequences or impact.1 event had code not found!.
Event or Problem Description
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between (b)(6)- (b)(6) 2025.This report summarizes 14 events for the failure: free or unrestricted flow.13 events had no health consequences or impact.1 event had a cancelled/aborted surgical procedure and temporary impairment.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Mfr report # 3015967359-2025-99445.Supplemental rationale corrected data: b5, h1, h6, h11.15 events were previously reported during the reporting quarter; however, 1 event was reported in error.14 previously reported events are included in this follow-up record.Product return status.3 devices were not available for evaluation.4 devices were received.7 devices had investigation types that have not yet been determined.Evaluation findings (results/components).3 devices: no findings available / part/component/sub-assembly term not applicable 4 devices: manufacturing process problem identified / membrane, adhesive 7 devices: results pending completion of investigation / part/component/sub-assembly term not applicable.Product disposition.2 devices: product not received.4 devices: scrapped by stryker.1 device: scrapped by customer.7 devices: product disposition is not yet determined.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: corrected data: b5, h1, h6, h11.14 events were previously reported during the reporting quarter; however, - 5 events were reported in error.- 9 previously reported events are included in this follow-up record.Product return status: 4 devices were not available for evaluation.5 devices were received.Evaluation findings (results/components): 4 devices: no findings available / part/component/sub-assembly term not applicable.5 devices: manufacturing process problem identified / membrane, adhesive.Product disposition: 3 devices: product not received.5 devices: scrapped by stryker.1 device: scrapped by customer.
Event or Problem Description
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between july 1 - september 30, 2025.This report summarizes 9 events for the failure: free or unrestricted flow.8 events had no health consequences or impact.1 event had a cancelled/aborted surgical procedure and temporary impairment.

• Brand Name: CLARIFIX
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): ENTELLUS MEDICAL, INC.; 3600 holly lane north; suite 40; plymouth MN 55447
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 23399782
• Report Number: 3015967359-2025-99445
• Device Sequence Number: 13273525
• Product Code: GEH
• UDI-Device Identifier: 00850002250404
• UDI-Public: 00850002250404
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 9
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CFX2000
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 09/30/2025; 09/30/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 01/27/2026; 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown